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口服普罗帕酮与奎尼丁作为有症状阵发性心房颤动患者初始治疗选择的比较:一项双盲随机试验。

Comparisons of oral propafenone and quinidine as an initial treatment option in patients with symptomatic paroxysmal atrial fibrillation: a double-blind, randomized trial.

作者信息

Lee S H, Chen S A, Chiang C E, Tai C T, Wen Z C, Wang S P, Chang M S

机构信息

Department of Medicine, Veterans General Hospital-Taipei, Taiwan.

出版信息

J Intern Med. 1996 Mar;239(3):253-60. doi: 10.1046/j.1365-2796.1996.451805000.x.

Abstract

OBJECTIVE

The main aim of the study was to evaluate the safety and efficacy of propafenone versus quinidine as an initial choice in treatment of symptomatic paroxysmal atrial fibrillation.

DESIGN

The study consisted of a 3-month treatment with oral propafenone hydrochloride or quinidine sulphate in patients with paroxysmal symptomatic atrial fibrillation, according to a double-blind randomized system.

SETTING

The study was performed in the out-patient clinic of university hospital.

MAIN OUTCOME MEASURES

The effects of the two drugs on attack frequency, ventricular rate and symptoms of symptomatic paroxysmal atrial fibrillation.

RESULTS

In the oral propafenone group (n = 48), two patients (4%) discontinued the treatment because of dizziness. In the 46 patients who continued the treatment, the attack frequency decreased from 11 +/- 3 times per week at baseline to 1 +/- 1 times per week after treatment (P < 0.01). Forty (87%) out of the 46 patients had effective response to oral propafenone (more than 75% reduction of symptomatic arrhythmic attacks) on a mean dose of 615 +/- 10 mg day-1; the decrease in attack frequency was from 10 +/- 3 to 1 +/- 1 times per week. Twenty-three (50%) patients were free from recurrence of symptomatic paroxysmal atrial fibrillation. Comparisons of symptom scores for patients (n = 23) with attacks of paroxysmal atrial fibrillation after oral propafenone treatment showed that there was a significantly lower symptom score of palpitation, asthenia, effort dyspnea, dizziness, rest dyspnea and chest oppression in attacks of paroxysmal atrial fibrillation after propafenone treatment (11.05 +/- 3.78 versus 7.60 +/- 3.46, P < 0.01). From the oral quinidine group (n = 48), two patients (4%) discontinued treatment because of gastrointestinal discomfort. In the 46 patients who continued the treatment, the attack frequency decreased from 11 +/- 4 times per week at baseline to 3 +/- 2 times per week after treatment (P < 0.01). Twenty-one (46%) out of the 46 patients had effective response to oral quinidine on a mean dose of 1067 +/- 462 mg day-1, with a decrease in attack frequency from 12 +/- 3 to 1 +/- 1 times per week. Only 10 (22%) patients were free from recurrence of paroxysmal atrial fibrillation. Comparisons of symptom scores for patients (n = 36) with attacks of paroxysmal atrial fibrillation after quinidine treatment showed that there was no significant decrease of symptom score in attacks of atrial fibrillation (10.65 +/- 3.92 versus 10.20 +/- 3.80, P = 0.57). Furthermore, the percentage decrease of ventricular rate during atrial fibrillation was significantly greater in patients with propafenone (-25 +/- 4% versus -8 +/- 3%, P < 0.01).

CONCLUSIONS

Oral propafenone appeared to be more effective than quinidine in suppressing attacks and alleviating symptoms of paroxysmal atrial fibrillation.

摘要

目的

本研究的主要目的是评估普罗帕酮与奎尼丁作为症状性阵发性心房颤动初始治疗选择的安全性和有效性。

设计

本研究根据双盲随机系统,对症状性阵发性心房颤动患者进行为期3个月的口服盐酸普罗帕酮或硫酸奎尼丁治疗。

地点

本研究在大学医院门诊进行。

主要观察指标

两种药物对症状性阵发性心房颤动发作频率、心室率及症状的影响。

结果

口服普罗帕酮组(n = 48),2例患者(4%)因头晕停药。在继续治疗的46例患者中,发作频率从基线时的每周11±3次降至治疗后的每周1±1次(P < 0.01)。46例患者中有40例(87%)在平均每日剂量615±10mg时对口服普罗帕酮有效(症状性心律失常发作减少超过75%);发作频率从每周10±3次降至每周1±1次。23例(50%)患者症状性阵发性心房颤动未复发。对口服普罗帕酮治疗后有阵发性心房颤动发作的患者(n = 23)的症状评分进行比较,结果显示普罗帕酮治疗后阵发性心房颤动发作时心悸、乏力、劳力性呼吸困难、头晕、静息性呼吸困难及胸闷的症状评分显著降低(11.05±3.78对7.60±3.46,P < 0.01)。口服奎尼丁组(n = 48),2例患者(4%)因胃肠道不适停药。在继续治疗的46例患者中,发作频率从基线时的每周11±4次降至治疗后的每周3±2次(P < 0.01)。46例患者中有21例(46%)在平均每日剂量1067±462mg时对口服奎尼丁有效,发作频率从每周12±3次降至每周1±1次。仅10例(22%)患者阵发性心房颤动未复发。对奎尼丁治疗后有阵发性心房颤动发作的患者(n = 36)的症状评分进行比较,结果显示心房颤动发作时症状评分无显著降低(10.65±3.92对10.20±3.80,P = 0.57)。此外,普罗帕酮治疗患者心房颤动时心室率下降百分比显著大于奎尼丁治疗患者(-25±4%对-8±3%,P < 0.01)。

结论

口服普罗帕酮在抑制症状性阵发性心房颤动发作和缓解症状方面似乎比奎尼丁更有效。

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